Duns Number:533186560
Device Description: QinFlow portable warmer system - the QiF warmer is a portable, inline blood and fluid warm QinFlow portable warmer system - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body.The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
Catalog Number
QPORT1000U-1
Brand Name
QinFlow portable warmer system
Version/Model Number
01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSB
Product Code Name
Warmer, Blood, Non-Electromagnetic Radiation
Public Device Record Key
f003dc9f-6f17-475f-ba06-6466b8f54177
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
July 11, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |